Senior Director, Medical Safety & Pharmacovigilance Remote with Travel A clinical-stage biotechnology company focused on developing innovative therapies for serious autoimmune and inflammatory diseases is seeking a Senior Director of Medical Safety & Pharmacovigilance. This individual will play a key role in strengthening safety and pharmacovigilance capabilities in support of a potential commercial launch and ongoing post-marketing activities. The successful candidate will provide medical leadership and clinical oversight to ensure robust safety surveillance, regulatory compliance, and high-quality pharmacovigilance operations.
Key Responsibilities:
Conduct medical review of Individual Case Safety Reports (ICSRs), including evaluation of case narratives, medical assessments, expectedness, and causality.
Provide medical expertise on complex, serious, and medically significant adverse event cases.
Support signal detection and ongoing safety surveillance activities through the review and interpretation of aggregate safety data.
Present and discuss safety findings in cross-functional safety governance meetings and review forums.
Perform quality review of safety data and ensure compliance with global pharmacovigilance regulations and reporting requirements.
Partner with Clinical Development, Regulatory Affairs, and other internal stakeholders to provide medical input on safety-related topics, including study protocols and investigator-facing documents.
Contribute to the development, maintenance, and continuous improvement of pharmacovigilance processes and documentation.
Interact with clinical investigators and external partners to obtain additional medical information and case follow-up as needed.
Support the preparation of safety narratives and other safety-related deliverables for clinical and post-marketing activities.
Qualifications:
MD, DO, or equivalent medical degree required.
Minimum of 5 years of experience in Drug Safety or Pharmacovigilance, including medical review of ICSRs.
Strong clinical judgment with demonstrated experience assessing causality, expectedness, and the medical significance of adverse events.
Experience collaborating with cross-functional teams and external investigators.
Prior experience supporting post-marketing safety activities preferred.
In-depth knowledge of global pharmacovigilance regulations, safety reporting requirements, and industry best practices.
Excellent communication, analytical, and problem-solving skills.
Apply now to join a growing patient focused company!
